Trials Test Antibodies to Prevent Hospital Infections

26 February 2018. Clinical trials are underway in the U.S. as part of a larger international project testing synthetic antibodies designed to prevent infections from bacteria often found in hospitals and clinics. The trials, sponsored by National Institute of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health, are testing 2 experimental therapies developed by MedImmune, the biologics division of drug maker AstraZeneca, in Gaithersburg, Maryland.

The intermediate-stage trials are testing monoclonal antibodies, synthetic and highly targeted proteins like those generated by the immune system, which in this case are designed for people with weakened immune systems to prevent dangerous bacterial infections. One of these bacteria, Pseudomonas aeruginosa, is responsible for pneumonia is health care settings, as well as blood stream infections. A second bacterium, Staphylococcus aureus, or staph, can also cause pneumonia and blood stream infections, as well as sepsis, and heart valve infections. In addition, strains of both bacteria are emerging that resist treatment from conventional antibiotics. A report issued by Centers for Disease Control and Prevention in 2016 says infections contracted in health care facilities are declining, but still pose a threat to hospitalized patients.

NIAID is supporting U.S. participation in COMBACTE, a European project to develop new treatments, including preventive drugs, to replace antibiotics that become ineffective in treating infections. The U.S. trials, led by researchers at Duke University, are enrolling 30 patients in intensive care units, among those most susceptible to infections. The studies are testing MedImmune’s antibody code-named MEDI3902 that aims to prevent infections from Pseudomonas aeruginosa, while suvratoxumab, formerly code-named MEDI4893, is designed to block infections from Staphylococcus aureus.

In both trials, patients are mechanically ventilated, or provided support in breathing. In one study, participants are colonized with Pseudomonas aeruginosa bacteria in the lower respiratory tract, then randomly assigned to receive an infusion of either MEDI3902 or placebo. Participants are then watched for signs of pneumonia forming in 3 weeks, and monitored for another 4 weeks after that. The second trial follows a similar procedure, where participants are colonized with staph bacteria, watched for pneumonia for 1 month, then monitored for another 6 months.

Research teams in both trials are watching for safety indicators, particularly serious adverse effects, as well as infections from the bacteria, either as pneumonia or in other forms. All patients give their consent to be part of the studies, either directly or through proxies.

MedImmune is sponsoring the studies, along with COMBACTE and NIAID. The Duke University team, led by infectious disease specialist Thomas Holland, is part of the Antibacterial Resistance Leadership Group, an ongoing clinical project testing new drugs and medical devices that address multidrug-resistant bacteria.

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